WINCO EXTRA STRENGTH COLD AND HOT MEDICATED- menthol patch

WinCo Extra Strength Cold and Hot Medicated by

Drug Labeling and Warnings

WinCo Extra Strength Cold and Hot Medicated by is a Otc medication manufactured, distributed, or labeled by WinCo Foods, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredient (in each patch)                                                                                     Purpose

Menthol 5%.............................................................................................................. Topical analgesic

PURPOSE

Uses

temporarily relieves minor pain associated with:

• arthritis
• simple backache
• bursitis
• tendonitis
• muscle strains
• muscle sprains
• bruises
• cramps

WARNINGS

Warnings

For external use only

WHEN USING

When using this product

• use only as directed
• do not bandage tightly or use with a heating pad
• avoid contact with eyes and mucous membranes
• do not apply to wounds or damaged skin

STOP USE

Stop use and ask a doctor if

• condition worsens
• sumptoms persist for more than 7 days or clear up and occur again within a few days
• redness is present
• skin irritation develops

PREGNANCY OR BREAST FEEDING

If pregnant or breast-feeding, ask a health professional before use

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center righta way

INDICATIONS & USAGE

Directions

adults and children 12 years of age and older:

• peel off protective backign and apply sticky side to affected area
• carefully remove backing from patch
• should be used up to 8 hours
• should be used no more than 3 times a day
• children under 12 years of age: consult a doctor

STORAGE AND HANDLING

Other information

• store at room temperature, not to exceed 86°F (30°C)

INACTIVE INGREDIENT

Inactive ingredients

1,3-butylene glycol, aloe vera (powder), dibutylhydroxytoluene, disodium edetate, d-sorbitol solution, gelatin, glycerine, kaolin, light liquid paraffin, magnesium aluminium hydrate, methacrylic acid butylacrylate copolymer, methyl parahydroxybenzoate, polysorbate 80, purified water, sodium metaphosphate, sodium polyacrylate, sorbitan monooleate, tartaric acid, titanium dioxide, tocopherol acetate

DOSAGE & ADMINISTRATION

DISTRIBUTED BY:

WINCO FOODS, LLC

BOISE, ID 83704

MADE IN KOREA

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

WINCO EXTRA STRENGTH COLD AND HOT MEDICATED 
menthol patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 67091-275
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	5 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
EDETATE DISODIUM (UNII: 7FLD91C86K)
SORBITOL (UNII: 506T60A25R)
KAOLIN (UNII: 24H4NWX5CO)
GELATIN (UNII: 2G86QN327L)
GLYCERIN (UNII: PDC6A3C0OX)
PARAFFIN (UNII: I9O0E3H2ZE)
MAGALDRATE (UNII: 6V88E24N5T)
METHYLPARABEN (UNII: A2I8C7HI9T)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
WATER (UNII: 059QF0KO0R)
SODIUM METAPHOSPHATE (UNII: 532IUT7IRV)
SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L)
TARTARIC ACID (UNII: W4888I119H)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 67091-275-05	5 in 1 BOX	02/07/2017
1		1 g in 1 PATCH; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	02/16/2015

Labeler - WinCo Foods, LLC (056098817)